DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1 – 12) drawn to a compound represented by the following Chemical Formula 1, an optical isomer thereof, or a pharmaceutically acceptable salt thereof: [Chemical Formula l]
PNG
media_image1.png
518
440
media_image1.png
Greyscale
wherein R1-4, X, Y1-3, L and ring A are defined and the species election of compound 80 of structure
PNG
media_image2.png
200
400
media_image2.png
Greyscale
in the reply filed on March 9th, 2026 is acknowledged.
Claim 14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II (a method for treating or preventing cancer), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 9th, 2026.
However, the initial search of the species election of compound 80 of structure
PNG
media_image2.png
200
400
media_image2.png
Greyscale
found that the species was free of the prior art. Thus, the search was expanded to include compounds wherein instant A is an heteroaryl and instant L is NH2; hence species wherein instant A is an heteroaryl and instant L is NH2 but all other substituents are the same as the elected species are rejoined. Nevertheless, any chemical species wherein instant A is not an heteroaryl, instant L is not NH2, and all other substituents differ from the elected species remain withdrawn. Moreover, the restriction requirement dated January 7th, 2026 between Groups I and II is still maintained.
Hence claims 1 – 12 are being examined on the merits herein.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 – 7, and 9 – 12 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 99/09016 to Wissner et. al. (herein after Wissner’016; cited on the IDS dated October 23rd, 2023).
Regarding claims 1 – 7, and 9 – 12, Wissner’016 teach compounds of formula 1:
PNG
media_image3.png
258
336
media_image3.png
Greyscale
(claims 3 – 5)(page 4 lines 18 – 19) wherein reference R1 and R4 are H (page 5 line 10); reference n is 0 (page 8 line 8); reference Z is -NH- (page 5 line 8); reference X is phenyl ring (page 4 line 23) substituted with an ortho-OCH3 (claims 6 and 7) (page 4 line 28) and meta-phenyl (page 4 line 30); reference R3 is -OCH3- (claim 2)(page 5 line 14); and wherein reference R2 is
PNG
media_image4.png
104
100
media_image4.png
Greyscale
(claim (page 6 line 16) wherein reference R5 are H (page 7 line 6).
Moreover, Wissner’016 teach that compounds of the disclosure which encompasses compounds with the above structural features, may be administered orally as well as by intravenous, intramuscular, or subcutaneous routes (page 45 lines 15 – 16) and mixed with adjuvants (claim 9) such as flavoring agents, coloring agents, preserving agents, and antioxidants (page 45 lines 20 – 22). Furthermore, Wissner’016 teach in an example that the compounds of the disclosure that compounds of the disclosure which encompasses compounds with the above structural features, inhibit EGFR (claim 10) (page 38 Table 1 lines 15 – 18 and page 40 Table 2 lines 15 – 30), and Human Epidermoid Tumors (A431), that is skin cancer (claim 12) in BALB/c nu/nu female mice (page 42 lines 40 – 52 and page 43 lines 1 – 27).
While, Wissner’016 fails to specifically teach an embodiment for the compound of chemical structure
PNG
media_image5.png
460
436
media_image5.png
Greyscale
; wherein instant X = N; instant R1 = -ORX2 wherein instant RX2 = CH3; wherein instant Y1 = Y2 = Y3 = CRY wherein instant RY = H; instant A = phenyl; instant L = -NH-; instant R3 is -CZ1=CZ2Z3- wherein instant Z1 = Z2 = Z3 = H; and instant R4 = -CH3; the prior art of Wissner’016 did teach all of the above structural features in lists of alternative structural features that were expected to work in combination with each other as compound species of reference formula 1 that can be formulated into pharmaceutical compositions useful in the treatment of cancer through the inhibition of HER2 and/or EGFR.
Regarding claim 11, recitation for the pharmaceutical composition of claim 10 wherein the pharmaceutical composition inhibits at least one selected from the group consisting of HER2 L869R, HER2 L755S, HER2 T798I, HER2 T862A, EGFR G719A, EGFR L861Q, EGFR S768I, EGFR G719A/S768I, and EGFR Dell9/T790M, this recitation is interpreted as a functional limitation that does not describe structural features of the composition but the capabilities of the composition. Thus, since the prior art of Wissner’016 taught all of the above structural features in lists of alternative structural features that were expected to work in pharmaceutical formulations useful in treating cancer through the inhibition of HER2 and/or EGFR and since these embodiments are structurally similar to the instant structural features a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979)(MPEP 2144.09(I)). Hence one of ordinary skill in the art would have a reasonable expectation that a pharmaceutical composition comprising the prior art optimized embodiment for a compound species of structure
PNG
media_image5.png
460
436
media_image5.png
Greyscale
would be capable of at least one selected from the group consisting of HER2 L869R, HER2 L755S, HER2 T798I, HER2 T862A, EGFR G719A, EGFR L861Q, EGFR S768I, EGFR G719A/S768I, and EGFR Dell9/T790M.
Therefore it would have been obvious before the effective filing date of the instant application to modify and optimize the teachings of Wissner’016 for compounds of reference formula I with the instant structural features. One of ordinary skill in the art would have been motivated to optimize the scaffold of reference formula I to improve the inhibition potential off the compound. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because the prior art taught that structural features in lists of alternative structural features that were expected to work.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 99/09016 to Wissner et. al. (herein after Wissner’016; cited on the IDS dated October 23rd, 2023) as applied to claims 1 – 7, and 9 – 12 above, and further in view of Ali et. al. ((2014) Input of Isosteric and Bioisosteric Approach in Drug Design, J. Chem. Soc. Pak., 36, page 150-169).
The teachings of Wissner’016 as it relates to claim 1, from which claim 8 depend, are given previously in this office action and are fully incorporated here.
However, while Wissner’016 teach the embodiments for a compound of chemical structure
PNG
media_image5.png
460
436
media_image5.png
Greyscale
; wherein instant X = N; instant R1 = -ORX2 wherein instant RX2 = CH3; wherein instant Y1 = Y2 = Y3 = CRY wherein instant RY = H; instant A = phenyl; instant L = -NH-; instant R3 is -CZ1=CZ2Z3- wherein instant Z1 = Z2 = Z3 = H; and instant R4 = -CH3; Wissmer’016 fails to teach a compound of structure
PNG
media_image6.png
456
454
media_image6.png
Greyscale
with the chemical name of N-(4-((5-(furan-2-yl)-2-methoxyphenyl)amino)-7-methoxyquinazolin-6-yl)acrylamide (claim 8).
Nevertheless, Ali et. al. teach that isosterism or bioisosterism is one of the approaches most frequently used in the design of new molecules (page 150 column 1 paragraph 1). Furthermore, Ali et. al. teach that this approach is now commonly used in advance drug design to optimize lead compound by rational molecular modification in order to improve its pharmacokinetic i.e. absorption, distribution, metabolism and excretion (ADME) or pharmacodynamic i.e. receptor, enzyme or channel level behavior (page 150 column 1 paragraph 1). Specifically, Ali et. al. teach that benzene/phenyl of structure
PNG
media_image7.png
200
400
media_image7.png
Greyscale
and furan of the structure
PNG
media_image8.png
266
250
media_image8.png
Greyscale
are ring equivalents (page 153 column 1 Figure 1). Thus Ali et. al. suggest the ability to substitute a phenyl/benzene ring for a furan ring with a reasonable expectation that compounds with either ring system would have similar biological properties.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the instant application to modify and optimize the teachings of Wissner’016 for compounds of reference formula I with the instant structural features in view of Ali et.al. that is to replace the phenyl with a furan ring. One of ordinary skill in the art would be motivated to make this modification and have a reasonable expectation of success because both phenyl/benzene and furan are ring equivalents and would be reasonable expected to at least have the same biological properties.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 – 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 –2, 4 – 6, and 11 – 20, of copending Application No. US 18/692229 to Ko et. al. (herein after Ko’229).
Ko’229 recite a compound represented by Formula (I), or a pharmaceutically acceptable salt or stereoisomer thereof:
PNG
media_image9.png
298
348
media_image9.png
Greyscale
(reference claim 1); wherein (reference) ring A is an unsubstituted furan (reference claim 5); (reference) Y1 is N; (reference) Y2 is CR2 wherein (reference) R2 is H (reference claim 2); (reference) Y3 is CR3 wherein (reference) R3 is H; (reference) X2 is H; (reference) X1 is CH3; (reference) L is
PNG
media_image10.png
96
186
media_image10.png
Greyscale
wherein (reference) Z is
PNG
media_image11.png
114
122
media_image11.png
Greyscale
and (reference) Z1-3 are H (reference claim 4). Moreover, Ko’229 recite the compound, or pharmaceutically acceptable salt or stereoisomer thereof according to (reference) claim 1; wherein: (reference) L is
PNG
media_image12.png
78
182
media_image12.png
Greyscale
(reference claim 6). Furthermore, Ko’229 recite a pharmaceutical composition comprising the one or more compound as of Formula (I) according to any one of as recited in (reference) claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof: and a pharmaceutically acceptable additive (reference claim 11).
However, Ko’229 fail to recite a compound of [Chemical Formula l]
PNG
media_image1.png
518
440
media_image1.png
Greyscale
wherein ring A is in the meta position from the amino group (instant claims 1 – 8). Moreover, Ko’229 fail to recite a pharmaceutical composition (instant claim 9) wherein the composition inhibits HER2 and/or EGFR (instant claim 10); wherein the pharmaceutical composition inhibits at least one selected from the group consisting of HER2 L869R, HER2 L755S, HER2 T798I, HER2 T862A, EGFR G719A, EGFR L861Q, EGFR S768I, EGFR G719A/S768I, and EGFR Dell9/T790M (instant claim 11); or wherein the cancer is one or more selected from the group consisting of a series of cancers (instant claim 12).
Nevertheless, given that the only difference between compounds of copending Ko’229 and the instant application is the location of ring A, that is in the meta position for Ko’229 and in the ortho position of the instant application both conflicting applications contain structural isomers of each other. Thus compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977) (MPEP 2144.09(II)).
Moreover, in regards to a pharmaceutical composition wherein the composition inhibits HER2 and/or EGFR (instant claim 10); wherein the pharmaceutical composition inhibits at least one selected from the group consisting of HER2 L869R, HER2 L755S, HER2 T798I, HER2 T862A, EGFR G719A, EGFR L861Q, EGFR S768I, EGFR G719A/S768I, and EGFR Dell9/T790M (instant claim 11); or wherein the cancer is one or more selected from the group consisting of a series of cancers (instant claim 12); these recitations are interpreted as functional limitations that do not describe structural features or components of the pharmaceutical composition but the capabilities of the pharmaceutical composition. Thus, since copending Ko’229 recites all of the above structural features in lists of alternative structural features and since these embodiments are structurally similar to the instant structural features a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979)(MPEP 2144.09(I)). Hence one of ordinary skill in the art would have a reasonable expectation that a pharmaceutical composition comprising compounds of copending Ko’229 modified for ring A in the meta position would be capable of inhibiting at least one HER2 and/or EGFR mutations selected from the group consisting of HER2 L869R, HER2 L755S, HER2 T798I, HER2 T862A, EGFR G719A, EGFR L861Q, EGFR S768I, EGFR G719A/S768I, and EGFR Dell9/T790M as a way of treating cancer.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1 – 12 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
Prosecution Insights